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Obstetrics & Gynecology 2000;96:261-265
© 2000 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Nicotine Replacement Prescription Practices of Obstetric and Pediatric Clinicians

CHERYL A. ONCKEN, MD, MPH, LORI PBERT, PhD, JUDITH K. OCKENE, PhD, JANE ZAPKA, ScD and ANNE STODDARD, ScD

From the Department of Medicine, University of Connecticut Health Center, Farmington, Connecticut; the Division of Preventive and Behavioral Medicine, University of Massachusetts School, Worcester, Massachusetts, and the Department of Biostatistics and Epidemiology, University of Massachusetts School of Public Health, Amherst, Massachusetts.

Address reprint requests to: Cheryl A. Oncken, MD, MPH University of Connecticut Health Center Department of Medicine (MC 3940) 263 Farmington Avenue Farmington, CT 06030 E-mail: oncken{at}nso2.uchc.edu


    Abstract
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
Objective: To assess smoking cessation counseling and nicotine replacement therapy prescription and recommendation practices among obstetric and pediatric providers.

Methods: We sent out a self-administered survey to 61 obstetric and pediatric nurse practitioners and physicians at six community health centers in the Boston area.

Results: Obstetric providers were more likely to view smoking cessation counseling as their responsibility in treating pregnant women than pediatric providers did in treating infants with mothers who smoked (mean ± standard deviation [95% confidence interval] 4.5 ± 0.76 [4.2, 4.8] versus 4.0 ± 0.8 [3.7, 4.3] on a five-point scale; P < .05). Obstetric providers believed that smoking cessation counseling was more effective than did pediatric providers (3.45 ± 1.1 [3.0, 3.9] versus 2.8 ± 0.8 [2.5, 3.1] on a five-point scale; P < .05) and were more likely to report provision of cessation assistance than pediatric providers (63% [44%, 82%] versus 17% [5%, 29%]; P < .05). Obstetric providers were more likely to prescribe or recommend over-the-counter nicotine replacement therapy than pediatric providers (44% [25%, 63%] versus 11% [1%, 21%], P = .004). Reasons for not prescribing nicotine replacement differed according to specialty; however, perceived lack of efficacy was not a typical reason given by clinicians in either specialty. Only two of 47 practitioners who did not prescribe or recommend those therapies listed that as a factor in their decisions.

Conclusion: We found that nicotine replacement therapies are commonly prescribed or recommended to pregnant smokers by obstetric providers, but less commonly to lactating women by pediatric providers.

Smoking during pregnancy and postpartum has statistically significant health risks for fetuses and newborns.1,2 Maternal smoking during pregnancy increases the risk of spontaneous abortion,3 fetal growth restriction,4 neurobehavioral deficits,5,6 and sudden infant death syndrome.7 Postpartum maternal smoking increases the risk of otitis media, asthma, and pneumonia in young children.8 Despite knowledge of those risks, most pregnant smokers do not quit during pregnancy or postpartum.9 Thus, there is critical need to evaluate therapeutic interventions that might help pregnant women and new mothers quit smoking.

Nicotine replacement therapies might decrease smoking rates in pregnant women and new mothers. In nonpregnant smokers, the therapies double smoking cessation rates compared with placebo.10–12 Smoking has well-known risks during pregnancy and postpartum, so it is important to determine whether nicotine replacement therapies are safe and effective for cessation in pregnant and lactating smokers. Another key issue is whether the use of nicotine replacement therapies is increasing during pregnancy or lactation. If practitioners are commonly prescribing those medications to pregnant and lactating smokers, it highlights the need to evaluate their safety and efficacy.

We report the results of a survey that examined smoking cessation and nicotine replacement therapy prescription and recommendation practices among obstetric and pediatric nurse practitioners and physicians.


    Materials and Methods
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
We sent a survey to assess smoking cessation counseling practices among nurses, nutritionists, nutrition assistants, midwives, nurse practitioners, and physicians. The instrument has been described elsewhere.13 The survey was conducted at six community health centers in the Boston, Massachusetts area from 1996–1997. We selected centers that had pediatric and obstetric providers. The surveys were distributed to 257 clinicians from obstetric; pediatric; and women, infant, and children clinics before implementation of smoking cessation programs. Questionnaires were anonymous to increase accuracy of reporting among clinicians. The survey assessed the following topics:

Role Perception:
In two or three items (depending on clinic) practitioners reported the extent to which they thought it was their responsibility to help pregnant women or new mothers stop smoking. Responses were on a five-point scale from 1 = not at all to 5 = great extent.

Effectiveness:
In two or three items practitioners were asked to report on how effective they thought counseling by clinicians can be for helping pregnant women or new mothers to stop smoking. Responses were on a five-point scale from 1 = not at all to 5 = great extent.

Confidence in Assistance:
In 2 or 3 items practitioners were asked to rate how confident they were in their ability to assist pregnant women or new mothers to stop smoking. Responses were rated on a five-point scale from 1 = not at all confident to 5 = very confident.

Knowledge:
Eight or nine questions (depending on specialty) were asked to determine practitioner knowledge about health risks of smoking during pregnancy and the usefulness of nicotine replacement therapy for smoking cessation.

Smoking Cessation Assistance:
Practitioners were asked whether they help 70% of women who smoke to stop smoking or maintain cessation. Practitioners who checked that response were categorized as providing smoking cessation assistance to most women.

Nicotine Replacement Therapy Discussion:
Practitioners were asked to estimate the proportion of smokers with whom they discussed the potential risks and benefits of nicotine replacement therapy during pregnancy or while breast feeding. Responses were on a scale of 1 = none to 4 = all.

Specific questions were developed only for physicians and nurse practitioners that focused on prescription or recommendation of nicotine replacement therapy for smoking cessation. Those questions were written before sustained-release bupropion (Glaxo Wellcome, Research Triangle Park, NC) was shown to be effective for smoking cessation,14 or before nicotine inhalers or nasal sprays were commonly prescribed for smoking cessation. Thus, questions were limited to prescription and recommendation practices for nicotine gum or patch.

Nicotine Replacement Therapy Usual Practice:
A hypothetical question was posed in which a woman who smoked 20 cigarettes per day was motivated to quit smoking with the aid of nicotine replacement therapy. Practitioners were asked whether it was their usual practice to prescribe or recommend such aides for smoking cessation. For obstetric providers the woman in question was pregnant; for pediatric providers she was breast-feeding an infant.

If the answer to that question was yes, practitioners were asked to rate how often they prescribed or recommended nicotine patches or gums for cessation. Choices for each of the four categories included a range from 1 = never to 5 = always.

If practitioners reported they would not typically prescribe or recommend nicotine replacement therapy in the hypothetical scenario, they were asked to give reasons why. Our instructions were to check all factors that contributed to their decisions, which included (1) it was the responsibility of another clinician to consider nicotine replacement therapy; (2) it was unethical to prescribe or recommend a potentially harmful substance during pregnancy or breast feeding; (3) there was risk of malpractice suits in the event of adverse reproductive outcomes; (4) it is not known whether the benefits outweigh the risks; (5) nicotine replacement therapy is not likely to be effective; and (6) concern that nicotine replacement therapy would lead to dependence on it. Practitioners could fill in a blank for other reasons.

Nicotine Replacement Therapy Intentions:
Practitioners were then asked, if there was definitive evidence that nicotine replacement therapy was safer than smoking for pregnant or breast-feeding smokers, would they prescribe or recommend it to the hypothetical woman. If the response was no, they were instructed to check all factors contributing to their decision, which included (1) it was unethical to prescribe or recommend a potentially harmful substance; (2) there was risk of a malpractice suit; (3) they were concerned about smoking concurrent with nicotine replacement therapy; or (4) pregnant women should be able to quit without such measures. Practitioners could fill in a response for other reasons.

For sample considerations, we originally estimated that less than 5% of pediatric providers and up to 50% of obstetric providers would prescribe or recommend nicotine replacement therapy. Based on those proportions, only 14 providers were needed per group to have 80% power to detect differences at the .05 level.

Categorical variables were described by frequency distributions, and differences between provider types were tested by the {chi}2 test of association or Fisher exact test, as appropriate. Scales were computed as the mean score of items that constituted the scale (ie, for measures of role, effectiveness, and confidence). For numeric characteristics and response scales, descriptive statistics (means and standard deviations) were used. Differences between means were tested with Student t test.


    Results
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
Response rates for the clinics were obstetrics, 50% (n = 57); pediatrics, 76% (n = 66); and women, infants, and children clinics, 80% (n = 54). The overall response rate was 69%. Of the total sample, 61 respondents were either physicians or nurse practitioners in obstetric or pediatric specialties.

The demographic characteristics of the obstetric (n = 25) and pediatric (n = 36) physicians and nurse practitioners are shown in Table 1Go. There were significant differences between provider specialties in attitudes, beliefs, and counseling practices with pregnant and lactating smokers. Obstetric providers were more likely to view smoking cessation counseling as part of their responsibility, to believe it was effective, and to be more confident in their abilities to deliver smoking counseling compared with pediatric providers. They were also more likely than pediatric providers to report that they currently provide smoking cessation assistance.


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Table 1. Characteristics and Smoking Cessation Counseling Practices*
 
Nicotine replacement therapy discussion and prescription or recommendation practices are shown in Table 2Go. For obstetric providers, ten of 24 reported discussing nicotine replacement therapy with none of their patients, seven of 24 discussed it with some, six of 24 discussed it with most, and one of 24 discussed it with all their patients. For pediatric providers, 23 of 35 reported discussing nicotine replacement therapy with none of breast-feeding mothers, seven of 35 discussed it with some, three of 35 discussed it with most, and two of 35 reported discussing it with all breast-feeding smokers. Most providers reported discussing nicotine replacement therapy with none of their patients, so the discussion variable was dichotomized into two categories, none and any. Table 2Go also shows that obstetric providers were more likely than pediatric providers to prescribe or recommend nicotine replacement therapy to the hypothetical woman. Both groups reported that their practices would change with definitive safety data; however, even with such data, obstetric providers still were more likely to prescribe nicotine replacement therapy than pediatric providers.


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Table 2. Nicotine Replacement Discussion, Prescription, and Recommendation Practices
 
Among 11 of 25 obstetric providers who responded affirmatively to the hypothetical question, there was similar reporting of prescription or recommendation of over-the-counter patches or gums in their own clinical practices. The responses "often" or "always" were checked only once for each of the four categories (prescribe patch, prescribe gum, recommend patch use, recommend gum use).

The reasons stated for not prescribing nicotine replacement therapy to pregnant or lactating women are shown in Table 3Go. Written-in responses for not prescribing from obstetrics providers included referring patients to other providers (one response) and lack of knowledge or experience (two responses). Written responses for pediatric providers included interference with primary provider (one response) and lack of knowledge or experience (eight responses). One pediatric provider would only prescribe such treatments if the mother were enrolled in a behavior modification program.


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Table 3. Reported Reasons for Not Prescribing or Recommending Nicotine Replacement to Pregnant or Lactating Smokers
 
If definitive safety data were available, most obstetric providers reported that they would prescribe nicotine replacement therapy for smoking cessation during pregnancy (Table 2Go). The reasons listed by the two obstetric providers who would not prescribe it included concern of legal liability and concern about concurrent smoking with nicotine replacement therapy. If there were definitive safety data for lactating smokers, more than half of pediatric providers reported that they would prescribe or recommend nicotine replacement therapy. Those who would not prescribe or recommend nicotine replacement therapy checked the following reasons: it was medically unethical (one response), legal liability concern (one response), and they believed mothers should be able to quit without such measures (one response). Written-in responses stated that it was not their responsibility as a provider (five responses), lack of experience (one response), and concern about negative impact on the infant (one response).


    Discussion
 Top
 Abstract
 Materials and Methods
 Results
 Discussion
 References
 
We found that 44% of obstetric care providers and 11% of pediatric care providers reported prescribing or recommending nicotine replacement therapy to pregnant or lactating smokers as their usual practice. The more frequent practice of prescribing nicotine replacement therapy among obstetric providers was likely related to our findings that they perceived smoking cessation counseling as their responsibility and that they believed that smoking cessation counseling by someone in their position was effective. Consequently, over half reported providing smoking cessation assistance to most of their patients, which in some circumstances included prescribing or recommending adjuvant nicotine replacement therapies. Pediatric providers typically prescribe medications only to infants, because mothers are technically not their patients. Nevertheless, in cases of maternal smoking, environmental tobacco exposure adversely affects infant health, which might explain why a small (but not negligible) proportion of pediatric providers prescribe nicotine replacement therapy to women who are breast-feeding infants.

Prescription practices among obstetric providers were consistent with a large survey of Texas obstetricians, which suggested that 29% of obstetricians prescribed nicotine replacement therapy to help their pregnant patients quit smoking.15 Another survey among family practitioners suggested that nicotine gum was prescribed to pregnant smokers by 10% of providers.16 Those surveys were conducted when nicotine replacement products were labeled as category X, or contraindicated during pregnancy. Nicotine gum is currently classified as category C during pregnancy; all other nicotine replacement products are classified as category D. Moreover, both products are now available for over-the-counter purchase. Those factors might explain why we found slightly higher prevalence of nicotine replacement therapy prescription or recommendation among obstetric providers compared with previous studies.

Reasons for not prescribing nicotine replacement therapy differed according to provider discipline. Obstetric providers had concerns mainly regarding the safety of nicotine replacement therapy (ie, benefit/risk ratio, ethical, and legal issues). Those concerns might be because preliminary studies evaluated only short-term effects of nicotine replacement therapy during pregnancy.17–20 There are no data available on long-term effects on fetal outcomes. Pediatric providers were more likely to report that it was not their responsibility to prescribe nicotine replacement therapy, but that of other providers. Most pediatric providers reported that they would prescribe nicotine replacement therapy if more definitive safety data were available (62% would prescribe it compared with the current 11% that do), so it is likely that safety was also a concern among them. It suggests that safety data could potentially change their perceived responsibility for providing smoking cessation assistance to breast-feeding mothers.

Perceived lack of effectiveness was not a typical reason they avoided prescribing or recommending nicotine replacement therapy (ie, only two of 47 practitioners listed that as influencing their prescription practices). We found that surprising given that almost no efficacy research evaluating the therapies during pregnancy or lactation has been conducted. One large study that compared the nicotine patch with placebo has been conducted in pregnant women, but the final results have not yet been published (Wisborg K, Jespersen L, Henrickson TB, Secher NJ. Nicotine patches to pregnant smokers—a randomized study. Presented at the First International Conference of the Society for Nicotine Research and Tobacco, Copenhagen, Denmark, August 23, 1998).

Limitations of our study include a relatively small sample of practitioners who work in an urban health-care setting. They serve primarily a Medicaid population with a relatively high smoking rate. Therefore, our results cannot be extrapolated to all obstetric and pediatric care providers. Nicotine replacement therapy prescription practices were similar to those in other surveys, but they still might represent a biased sample of providers. Reported prescription patterns might be higher than those of providers who did not return the questionnaire. Questions were hypothetical and self-reported, so the degree to which they differed from actual practice patterns is not known. The centers were not chosen randomly; however, the similarity of the setting, system, and patient population among those studied improves the probability that any observed differences were specific to providers and not the setting.

Suggestions for future research include an expanded survey to examine attitudes of a larger population of providers and correlate their attitudes with actual practices and clinical outcomes. Further research also is needed to establish the clinical safety and efficacy of nicotine replacement therapy in pregnant and lactating smokers.


    Footnotes
 
This study was supported by NHLBI grant no. RO1-HL51319-03 and in part by NIH General Clinical Research Center Grant # MO1RR006192.

PII S0029-7844(00)00905-4

Received November 12, 1999. Received in revised form March 6, 2000. Accepted March 30, 2000.


    References
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 Materials and Methods
 Results
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1. Walsh RA. Effects of maternal smoking on adverse pregnancy outcomes: Examination of the criteria for causation. Hum Biol 1994;66:1059–92.[Medline]

2. Stoddard JJ, Miller T. Impact of parental smoking on the prevalence of wheezing respiratory illness in children. Am J Epidemiol 1995;141:96–102.[Abstract/Free Full Text]

3. Armstrong BG, McDonald AD, Sloan M. Cigarette, alcohol, and coffee consumption and spontaneous abortion. Am J Public Health 1992;82:85–7.[Abstract/Free Full Text]

4. Cliver SP, Goldenberg RL, Cutter GR, Hoffman HJ, Davis RO, Nelson KG. The effect of cigarette smoking on neonatal anthropometric measurements. Obstet Gynecol 1995;85:625–30.[Abstract]

5. Fried PA, Watkinson B, Gray R. Differential effects on cognitive functioning in 9–12 year-olds prenatally exposed to cigarettes and marijuana. Neurotoxicol Teratol 1998;20:293–306.[Medline]

6. Tong S, McMichael AJ. Maternal smoking and neuropsychological development in childhood: A review of the evidence. Dev Med Child Neurol 1992;34:191–7.[Medline]

7. DiFranza R, Lew RA. Effect of maternal cigarette smoking on pregnancy complications and sudden infant death syndrome. J Fam Pract 1995;40:385–94.[Medline]

8. Law MR, Hackshaw AK. Environmental tobacco smoke. Br Med Bull 1996;52:22–34.[Abstract/Free Full Text]

9. Floyd RL, Rimer BK, Giovino GA, Mullen PD, Sullivan SE. A review of smoking and pregnancy: Effects on pregnancy outcomes and cessation efforts. Annu Rev Public Health 1993;14:379–411.[Medline]

10. Fiore MC, Smith SS, Jorenby DE, Baker TB. The effectiveness of the nicotine patch for smoking cessation. JAMA 1994;271:1940–7.[Abstract]

11. Smoking Cessation Clinical Practice Guidelines for Panel and Staff. The Agency for Health Care Policy and Research Smoking Cessation. Clinical Practice Guideline. JAMA 1996;275:1270–80.[Abstract]

12. Henningfield JE. Nicotine medications for smoking cessation. N Engl J Med 1995;333:1196–203.[Free Full Text]

13. Zapka JG, Pbert L, Stoddard A, Ockene JK, Goins KV, Bonnollo D. Smoking cessation counseling with pregnant and postpartum women: A survey of community health care providers. Am J Public Health 2000;90:78–84.[Abstract/Free Full Text]

14. Hurt RD, Sachs DP, Glover ED, Offord KP, Johnston JA, Dale LC, et al. A comparison of sustained-release bupropion and placebo for smoking cessation. N Engl J Med 1997;337:1195–202.[Abstract/Free Full Text]

15. Mullen PD, Pollack KI, Titus JP, Sockrider MM, Moy JG. Prenatal smoking cessation counseling by Texas obstetricians. Birth 1998; 25:25–31.[Medline]

16. Hickner J, Cousineau A, Mesimer S. Smoking cessation during pregnancy: Strategies used by Michigan family physicians. J Am Board Fam Pract 1990;3:39–42.

17. Oncken CA, Hatsukami DK, Lupo VR, Lando HA, Gibeau LM, Hansen RJ. Effects of short-term nicotine gum use in pregnant smokers. Clin Pharmacol Ther 1996;59:654–61.[Medline]

18. Oncken CA, Hardardottir H, Hatsukami D, Lupo V, Rodis J, Smeltzer J. Effects of transdermal nicotine or smoking on nicotine concentrations and maternal-fetal hemodynamics. Obstet Gynecol 1997;90:569–74.[Abstract]

19. Ogborn PL, Hurt RD, Croghan IT, Schroeder DR, Ramin KD, Moyer TP. Nicotine patch use in pregnant smokers: Nicotine and cotinine levels and fetal effects. Am J Obstet Gynecol 1999;181:736–43.[Medline]

20. Wright LN, Thorp JM, Kuller JA, Shrewsbury RP, Ananth C, Hartmann K. Transdermal nicotine replacement in pregnancy: Maternal pharmacokinetics and fetal effect. Am J Obstet Gynecol 1997;176:1090–4.[Medline]




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